[The Requirements of Medical Device Market Access in India]

Zhongguo Yi Liao Qi Xie Za Zhi. 2016 Jan;40(1):61-3.
[Article in Chinese]

Abstract

This paper introduces the premarket registration procedures and the post market regulatory requirements in India. According to Indian medical device act and related medical regulations on medical device, this is a preliminary discussion on the registration management system to provide referance for foreign medical device to enter India market.

MeSH terms

  • Equipment and Supplies / economics*
  • Equipment and Supplies / standards*
  • India